Table 2.

Adverse Events Overview

EventDual Therapy (n = 126)Triple Therapy (n = 123)P Value
Summary of AEs
Patients with ≥1 AE
Total
88 (70)
197
93 (76)
207
.307
Patients with ≥1 grade 2 to 4 AE
Total
15 (12)
17
18 (15)
30
.525
Patients with ≥1 serious AE
Total
6 (5)
6
6 (5)
7
.966
Discontinuation due to AEs1 (1)a2 (2)b.547
Deaths00NA
Adverse events that occurred in at least 5% of participants in either group
Respiratory: patients with ≥1 AE
Total
31 (25)
42
29 (24)
36
.850
Infections: patients with ≥1 AE
Total
22 (17)
26
18 (15)
23
.544
Digestive: patients with ≥1 AE
Total
18 (14)
22
22 (18)
27
.439
Muscular or skeletal: patients with ≥1 AE
Total
16 (13)
17
22 (18)
27
.255
Neuropsychiatric: patients with ≥1 AE
Total
12 (10)
15
12 (10)
15
.950
Metabolic: patients with ≥1 AE
Total
13 (10)
15
8 (7)
9
.279
Genitourinary: patients with ≥1 AE
Total
8 (6)
9
6 (5)
6
.614
General disorders: patients with ≥1 AE
Total
7 (6)
8
7 (6)
8
.963
Ear, nose, throat: patients with ≥1 AE
Total
7 (6)
7
8 (7)
8
.753
Oral cavity: patients with ≥1 AE
Total
3 (2)
5
7 (6)
7
.184
EventDual Therapy (n = 126)Triple Therapy (n = 123)P Value
Summary of AEs
Patients with ≥1 AE
Total
88 (70)
197
93 (76)
207
.307
Patients with ≥1 grade 2 to 4 AE
Total
15 (12)
17
18 (15)
30
.525
Patients with ≥1 serious AE
Total
6 (5)
6
6 (5)
7
.966
Discontinuation due to AEs1 (1)a2 (2)b.547
Deaths00NA
Adverse events that occurred in at least 5% of participants in either group
Respiratory: patients with ≥1 AE
Total
31 (25)
42
29 (24)
36
.850
Infections: patients with ≥1 AE
Total
22 (17)
26
18 (15)
23
.544
Digestive: patients with ≥1 AE
Total
18 (14)
22
22 (18)
27
.439
Muscular or skeletal: patients with ≥1 AE
Total
16 (13)
17
22 (18)
27
.255
Neuropsychiatric: patients with ≥1 AE
Total
12 (10)
15
12 (10)
15
.950
Metabolic: patients with ≥1 AE
Total
13 (10)
15
8 (7)
9
.279
Genitourinary: patients with ≥1 AE
Total
8 (6)
9
6 (5)
6
.614
General disorders: patients with ≥1 AE
Total
7 (6)
8
7 (6)
8
.963
Ear, nose, throat: patients with ≥1 AE
Total
7 (6)
7
8 (7)
8
.753
Oral cavity: patients with ≥1 AE
Total
3 (2)
5
7 (6)
7
.184

Data are n (%). Dual therapy = switching to darunavir/r + lamivudine. Triple therapy = maintain triple therapy with darunavir/r + 2 nucleos(t)ide reverse transcriptase inhibitors.

Abbreviation: AE, adverse event.

aOne case of hyperlipidemia.

bOne case of diarrhea, one case of Hodgkin’s lymphoma.

Table 2.

Adverse Events Overview

EventDual Therapy (n = 126)Triple Therapy (n = 123)P Value
Summary of AEs
Patients with ≥1 AE
Total
88 (70)
197
93 (76)
207
.307
Patients with ≥1 grade 2 to 4 AE
Total
15 (12)
17
18 (15)
30
.525
Patients with ≥1 serious AE
Total
6 (5)
6
6 (5)
7
.966
Discontinuation due to AEs1 (1)a2 (2)b.547
Deaths00NA
Adverse events that occurred in at least 5% of participants in either group
Respiratory: patients with ≥1 AE
Total
31 (25)
42
29 (24)
36
.850
Infections: patients with ≥1 AE
Total
22 (17)
26
18 (15)
23
.544
Digestive: patients with ≥1 AE
Total
18 (14)
22
22 (18)
27
.439
Muscular or skeletal: patients with ≥1 AE
Total
16 (13)
17
22 (18)
27
.255
Neuropsychiatric: patients with ≥1 AE
Total
12 (10)
15
12 (10)
15
.950
Metabolic: patients with ≥1 AE
Total
13 (10)
15
8 (7)
9
.279
Genitourinary: patients with ≥1 AE
Total
8 (6)
9
6 (5)
6
.614
General disorders: patients with ≥1 AE
Total
7 (6)
8
7 (6)
8
.963
Ear, nose, throat: patients with ≥1 AE
Total
7 (6)
7
8 (7)
8
.753
Oral cavity: patients with ≥1 AE
Total
3 (2)
5
7 (6)
7
.184
EventDual Therapy (n = 126)Triple Therapy (n = 123)P Value
Summary of AEs
Patients with ≥1 AE
Total
88 (70)
197
93 (76)
207
.307
Patients with ≥1 grade 2 to 4 AE
Total
15 (12)
17
18 (15)
30
.525
Patients with ≥1 serious AE
Total
6 (5)
6
6 (5)
7
.966
Discontinuation due to AEs1 (1)a2 (2)b.547
Deaths00NA
Adverse events that occurred in at least 5% of participants in either group
Respiratory: patients with ≥1 AE
Total
31 (25)
42
29 (24)
36
.850
Infections: patients with ≥1 AE
Total
22 (17)
26
18 (15)
23
.544
Digestive: patients with ≥1 AE
Total
18 (14)
22
22 (18)
27
.439
Muscular or skeletal: patients with ≥1 AE
Total
16 (13)
17
22 (18)
27
.255
Neuropsychiatric: patients with ≥1 AE
Total
12 (10)
15
12 (10)
15
.950
Metabolic: patients with ≥1 AE
Total
13 (10)
15
8 (7)
9
.279
Genitourinary: patients with ≥1 AE
Total
8 (6)
9
6 (5)
6
.614
General disorders: patients with ≥1 AE
Total
7 (6)
8
7 (6)
8
.963
Ear, nose, throat: patients with ≥1 AE
Total
7 (6)
7
8 (7)
8
.753
Oral cavity: patients with ≥1 AE
Total
3 (2)
5
7 (6)
7
.184

Data are n (%). Dual therapy = switching to darunavir/r + lamivudine. Triple therapy = maintain triple therapy with darunavir/r + 2 nucleos(t)ide reverse transcriptase inhibitors.

Abbreviation: AE, adverse event.

aOne case of hyperlipidemia.

bOne case of diarrhea, one case of Hodgkin’s lymphoma.

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